Secukinumab: Phase III data

The double-blind, international Phase III FEATURE trial in 177 patients with moderate to severe chronic plaque-type psoriasis showed that 150 and 300 mg subcutaneous secukinumab delivered via pre-filled syringes each met the co-primary endpoints of improving PASI 75 and IGA response rates at week 12 vs. placebo. Specifically, 69.5% of patients receiving low-dose secukinumab and 75.9% of patients receiving high-dose secukinumab achieved a PASI 75 response at week 12 vs. 0% for placebo (p<0.0001 for both). Additionally, 52.5% of patients receiving low-dose secukinumab and 69% of patients receiving high-dose secukinumab achieved an IGA response, defined as a score of 0 or 1 on a 5-point scale, at week 12 vs. 0% for placebo (p<0.0001).

Both doses of secukinumab also met all secondary endpoints vs. placebo. PASI 90 response rates at week 12 were 27% for low-dose secukinumab and 59% for high-dose secukinumab vs. 0% for placebo (p<0.0001 for both). Overall mean SIAQ scores increased from baseline to week 12 by 0.83 points for feelings about self-injections, 1.14 points for self-confidence and 1.52 points for satisfaction across all groups. The most common adverse events reported were diarrhea, nasopharyngitis, headache and pyrexia, and the overall incidence of adverse events was similar across all treatment arms. Patients received 150 or 300 mg secukinumab or placebo at week 0, 1, 2, 3, 4 and 8, and then once every 4 weeks to week 48. At week 12, non-PASI 75 responders receiving placebo were re-randomized to 150 or 300 mg secukinumab once weekly until week 15 and then once every 4 weeks through week 48. Data were presented at the American Academy of Dermatology meeting in Denver. ...